GE Proteus XR/A radiographic system
FDA device recall Z-0550-2025 · posted 2024-11-25 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare (China) Co., Ltd.
- Reason for recall
- Steel cables in the Wall Stand for certain Proteus XR/a systems serviced by GE HealthCare have not been replaced at the intervals detailed in the Preventative Maintenance Action List.
- Action taken
- An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/24/24 was sent to customers. Actions to be taken by Customer/User " You can continue to use the system for table exams without limitations. " You can continue to use the wall stand for exams where the patient does not have any part of their body underneath the bucky. " Do not perform exams where the patient has any body part underneath the bucky until the Wall Stand steel cable has been inspected and if necessary, has been replaced. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to RECALL.17148@gehealthcare.com GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Equipment maintenance
- Status
- Open, Classified
- Product code
- KPR
- Quantity affected
- 956 systems
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2024-10-24
- Date posted
- 2024-11-25
- Location
- Beijing, China
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SILHOUETTE FC (K993090) | Ge Medical Systems, Inc. | 1999-10-01 |